The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco V-pro 1 And V-pro 1 Plus Low Temperature Sterilization Units.
| Device ID | K111810 |
| 510k Number | K111810 |
| Device Name: | AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS |
| Classification | Sterilizer, Chemical |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Robert Sullivan |
| Correspondent | Robert Sullivan STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | MLR |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-27 |
| Decision Date | 2011-09-02 |
| Summary: | summary |